A Randomized and Controlled Study of the Use of Orthopulse Photobiomodulation for Acceleration of Orthodontic Tooth Movement With Fixed Appliances
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- The primary endpoint of this PMCF study is the rate of tooth alignment.
研究概览
简要总结
This PMCF study evaluates the safety and performance of OrthoPulse photobiomodulation to accelerate tooth movement during alignment with fixed appliances.
详细描述
The purpose of the current clinical investigation performed in form of a post-market clinical follow-up (PMCF) study is to evaluate the performance of OrthoPulse by means of confirming the hypothesis that Subjects in the interventional group (group 1) will have a statistically significant average faster rate of tooth movement during the alignment phase than the average of subjects in the control group (group 2) (estimated 1.8x faster tooth movement) and to substantiate the clinical data for the application of OrthoPulse in case of fixed appliances (brackets).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
None (Open Label)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: at least 18 years
- •Indication for an orthodontic treatment with fixed appliances
- •Presence of a written declaration
- •Permanent dentition
- •Class I-III malocclusion
- •Between 4-10mm of crowding (estimated traditionally) in anterior teeth in mandibular arch (This will depend on the time we choose for the endpoint)
排除标准
- •Simultaneous participation in another clinical investigation or study
- •Prior participation in this study
- •Persons who have been placed in an institution as a result of an administrative or judicial order
- •Persons who are dependent on the sponsor, Investigator or the investigation site
- •Anterior cross bite
- •Spaces between anterior teeth
- •Extractions or missing permanent teeth (except for third molars)
- •No anticipated requirement of auxiliary appliances and/or elastics during treatment during alignment phase
- •Acute oral infection or periodontal disease
- •Active caries
- •Pregnant patients or patients planning to become pregnant
结局指标
主要结局
The primary endpoint of this PMCF study is the rate of tooth alignment.
时间窗: 42 days after start of treatment
The primary endpoint of this PMCF study is the rate of tooth alignment as per Little's irregularity index LII (measured as the distance of linear displacement in mm divided by a unit of time between the lower arch anterior 6 teeth) during the time between baseline and 42 days after start of treatment.
次要结局
未报告次要终点